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U.S. Department of Health and Human Services

Class 2 Device Recall MD 4

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 Class 2 Device Recall MD 4see related information
Date Initiated by FirmApril 06, 2006
Date PostedMay 06, 2006
Recall Status1 Terminated 3 on May 21, 2008
Recall NumberZ-0852-06
Recall Event ID 35177
510(K)NumberK961374 
Product Classification X Ray System - Product Code JAA
ProductMD4 X-ray system
Code Information Site numbers 102550 (20279385), 103023, 38783, 102562 (20279430), 83957, 101155, 82628, 38442, 83038, 13721, 85034, 102583, 80306, 41156, 38993, 84930, X1321, 41032, X1077, 100014, 50328, 17656, 83367, 38586, 100954, 76834, 87176, 41426, 104137, 82800, 103651, 10388, 41111, 17622, 13918, 103377, 101038, X0934, 102034, 52471, 76804, 50251, 44898, 13258, 86545, 101863, 38587, 103043 (20283876), 82688, 38635, 47160, 14099, 45042, 38917, 101156 (20278521), 86328, 38501, 13879, 41439, 41069, 76975, X1277, 100637, X1078, 35484, 101759, 84463, 105022, X1751, 76877, 13172, 38944, 41143, 85694, 87140, 59546, 13704, 10458, 45039, 76869, 52455, 84892, 41271, 87302, 6842, 41031, 41000, X0662, 87030, 76808, 6838, 62938, 86218, 85491, 50340, 82687, 38912, 101153, 103210
FEI Number 1000524572
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information ContactSarah Baxter
425-487-7665
Manufacturer Reason
for Recall		Potential for unexpected table movement.
FDA Determined
Cause 2		Other
ActionOn 4/6/06 the firm issued a letter to consignees advising of the problem. The letter advises consignees to conduct a test on their unit(s) for a possible short until the firm is able to upgrade the units.
Quantity in Commerce100 units
DistributionUnits were distributed to hospitals and medical centers located throughou the US.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAA
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